Kenneth Lute

It would seem senseless to start the construction of a house without a blueprint, prepare an unfamiliar dinner without using a recipe or start a season aiming for a championship without a play book. Unfortunately in the biopharm industry, far too often such conventional wisdom is lost in the haste to deliver now, and the consequences can be disastrous. 

Product development challenges have never been more formidable. Recent economic downturns, along with increasing concerns regarding the safety of marketed drugs,

  have captured a lot of attention. With decreasing investment resources,

  and stiffening competition for subject and site recruitment,

  today's market will not tolerate missteps. 

Gone are the days of seeding trials, exploratory fishing expeditions, do-over trials, and the like. Today, success is predicated on implementing an efficient and effective program, while calling for optimally designed trials that are conducted correctly the first time. Strategic development planning is the means to this end. 

Ideally, strategic development planning should begin with early discussions prior to the start of any activity. The  "guidebook" for planning is the integrated development plan. And this plan incorporates all activities related to the entire development program. 

As the goal for development is to obtain marketing authorization with a desired indication statement and label claim(s), it is critical that all activities be aligned and integrated to serve that purpose. In this regard, the development plan is an excellent tool to maximize efficiency and pull together supportive information, while also serving to coordinate efforts. It ensures and reminds stakeholders that all activities funnel to a common purpose. 

Despite the fact that early strategic planning requires an up-front investment of both time and money, the benefits reaped during the development program far outweigh the initial investments. 

An elegant development plan demonstrates a level of thoroughness that is appreciated by regulators and investors alike. Much like an insurance policy, a development plan offers reassurance to stakeholders, providing a level of security that may be fostered over time.

The utility of a development plan lies in its ability to organize and integrate a multitude of information in one place. More than simply a list of tasks to be completed, it provides a temporal link of activities occurring across disciplines. This is of value not only with regard to streamlining activities, but also in terms of contingency planning. 

The integrated development plan is essentially composed of several sub-plans, among these are:  

Chemistry manufacturing and controls (CMC) development plan

Regulatory strategy/target product profile (TPP)

The preclinical, CMC, and regulatory plans are designed to support a clinical program through each study. Therefore, considerable attention must be given to their timing. For example, it is important for the preclinical and CMC plans to precede sufficiently the clinical plan to ensure there are adequate toxicology data, as well as sufficient investigational product, to support planned preclinical and clinical studies. The integration of all these activities can only be accomplished with careful risk management planning. 

Marketing approval is granted based on the ability of the applicant's data to support the proposed indication and label claims. Therefore, it is imperative that each plan be crafted and constantly reevaluated against the marketing claims. Unfortunately, with personnel turnover, shifting priorities, and the occasional catastrophe, it is all too easy to get bogged down in the details and lose sight of the objective. 

This is where a solid development plan can mean the difference between failure and success. In summary, it is:  

A unique, comprehensive, global road map for the development of the compound

A way to identify key decision points throughout the development, also known as go/no-go decision points

One place where all activities, regulatory strategy, and commercial considerations are laid out

Adaptable as new information about the product, indication, and regulatory environment becomes available

A critical "living" reference for the development team and other stakeholders

In addition to being something that is not quickly or easily put together, the integrated development plan is also not: 

 While this may be a major focus, there are other significant activities supporting the clinical program that need to be considered. 

 Ongoing review of the plan is needed, as data from studies and other activities become available, new regulatory guidance and requirements emerge, or new information about the target indication becomes known. 

Written or maintained by only one person.

 The complexity of the plan requires ongoing assessment and input from the entire team to fully appreciate the impact of new information. 

Successful strategic development planning is done by a team of experts, who should include but not be limited to the following individuals:  

Several core questions should be addressed at the outset of strategic planning. The answers will help define the scope and breadth needed for the integrated development plan. 

Once the desired target indication statement and proposed label claims are determined, the next step is to work backward with the end in mind to shape the program based on logistical and operational considerations. The questions that should be addressed include, but may not be limited to:  

Which elements are required to support the proposed label claims (i.e., critical path) and which are nice to have?

What resource and time constraints must be considered?

Articles

An integrated product development plan designed early increases the odds of on time success.

Kenneth Lute

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Strategy First